Cranial electrotherapy stimulation in the treatment of posttraumatic stress disorder: A feasibility, safety, and preliminary efficacy study

Background

Neuromodulation of brain circuits important for affect, behavior, and cognition may decrease the symptomatology and functional impairment of military veterans suffering from posttraumatic stress disorder (PTSD). Cranial electrotherapy stimulation (CES) techniques, such as Alpha-Stim®, have demonstrated preliminary benefit for symptoms that commonly co-occur with PTSD, such as pain, anxiety, depression, and insomnia. However, CES has not yet been specifically tested as a treatment for PTSD. The objective of this open-label pilot study was to examine feasibility, safety, and preliminary efficacy of Alpha-Stim® for treatment of PTSD.

Methods

Open-label Alpha-Stim® was administered to nine veterans who were diagnosed with PTSD via structured interview (Clinician-Administered PTSD Scale for DSM-5 [CAPS-5]) and were taking at least one psychotropic medication. Treatment consisted of 20 CES sessions administered at home over 40 days. Effects on PTSD symptoms, functioning, depression symptoms, pain, anxiety symptoms, and insomnia were assessed at baseline and every week of treatment for four weeks. Effects on PTSD symptoms, depression symptoms, and pain were assessed one month and three months post-treatment.

Results

Seven patients (78%) successfully completed treatment. There were no adverse events. Following four weeks of Alpha-Stim® treatment, PTSD symptoms decreased by 38%, depression symptoms decreased by 52%, insomnia decreased by 34%, and pain decreased by 11%. Significant improvements in PTSD and depression, but not pain, persisted at one-month and three-months posttreatment. Presumptive loss of diagnosis rates (i.e., PTSD Checklist for DSM-5 total score below 33) immediately following treatment and one and three months later were 43%, 33%, and 29%, respectively.

Conclusions

Alpha-Stim® showed an excellent safety profile with no adverse effects. The results suggest preliminary efficacy for improving PTSD symptoms as well as concomitant depression symptoms, insomnia, and pain. Limitations of this pilot study include the open-label, uncontrolled design and small sample size. These results support additional larger, randomized controlled trials of Alpha-Stim® for veterans with PTSD.